FDA UDI
In Commercial Distribution
🇺🇸 United States
X°Port Lung Preservation Solution
DI: 07540161670269
·
Model: 910-0003-8L-PKG
·
Traferox Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- X°Port Lung Preservation Solution
- Primary DI
- 07540161670269
- Version / Model
- 910-0003-8L-PKG
- Company Name
- Traferox Technologies Inc
- Labeler DUNS
- 204279512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-11
- Public Version
- 1
- Public Version Date
- 2025-09-19
- Public Version Status
- New
- Public Device Record Key
- 6fddb932-bdf6-4f26-834f-7a10c3f716db
Device Description
The X°Port Lung Preservation Solution is used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. Package Size: 3 x 2000ml and 2 x 1000ml.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | Gastroenterology, Urology | 876.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18004 | Donor-organ/tissue/cell preservation solution | A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540161670269 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243870 | 000 |